Female incontinence prevention device

ABSTRACT

The disclosure provides an incontinence prevention device provided with a loop type retention structure. The retention structure is in the form of a closed loop attached to the distal end of a shaft. The shaft is configured to function as an incontinence prevention device. The retention structure projecting laterally from and configured non-concentrically along the longitudinal axis of the shaft retains the incontinence prevention device within the patient. The retention structure may additionally include a protuberance extending therefrom. There is further provided a method for using the urethral catheter.

FIELD OF INVENTION

The present invention relates generally to incontinence preventiondevices, and more particularly to an incontinence prevention deviceshaving a non-concentric retention structures.

BACKGROUND OF INVENTION

Many adults suffer urinary incontinence although urinary incontinence ismore common in women than in men. The increased frequency in women isdue primarily to the laxity of the bladder support structures resultingfrom pregnancy and aging. Surgical correction is possible in some cases,but surgery is invasive, costly and dangerous. Urethral incontinenceprevention devices, such as for example catheters, plugs and othersimilar devices, in most cases offer a better solution but can becumbersome to use, can be expelled during bowel movements, and aretypically relatively expensive to manufacture.

There are a wide variety of incontinence prevention devices available,including: catheters that have lumen for urine to flow through; valvedcatheters; plugs that prevent the flow of urine until the plug isremoved; and cylindrical supports against which the spinchter seals theurethra to prevent the flow of urine. Foley catheters are one type ofcommonly used catheter. Foley catheters are essentially elongated tubes.They are placed in the urethra to drain urine through the central lumen.An inflatable balloon is included near the distal end of the tube servesas a retention structure. When inflated, the balloon holds the catheterin place. The proximal end of a Foley catheter typically has two ports:a drainage port to drain urine from the bladder and a balloon inflationport to inflate and deflate the balloon. The drainage port creates apermanent opening between the bladder and outside environment. Becausethe bladder is continuously emptied, the bladder's dome continuouslyrests on the tip of the catheter above the retention balloon causingcompression, irritation and erosion of tissue as well as other tissueproblems. Therefore, a need exists for a retention structure that doesnot protrude into the bladder such that it contacts the bladder's dome.

Plugs totally block the flow of urine. Therefore, the plugs typicallyrequire removal for the user to urinate. After removal, the old plug isnot sterile and a new sterile plug must inserted into the urethra Plugs'retention structures are typically cumbersome to operate and traumaticto the tissue. Thus, improper use can lead to irritation and infectionfrom tissue traumatization. Further, the retention devices on the plugsare typically fluid filled and therefore relatively complex tomanufacture. Therefore, a need exists for an incontinence preventiondevice that provides an atraumatic and simple means for insertion andremoval and further reduces manufacturing costs.

Further, some urethral incontinence devices include open loop or pigtailtype retention structures. These devices may be expelled when a usertenses the abdomen, such as when a user bears down during a bowelmovement, because of a phenomenon called bladder neck drop oftenassociated with incontinent female patients. With bladder neck drop, thebladder neck extends downward to encompass at least a portion of theurethra. The open loop type retention structures are thought to dropinto the downward extension and thereafter could be entrapped in theurethra rendering it quasi-rectilinear as the bladder neck resumes itsoriginal shape. The improperly positioned device no longer functionsproperly and the quasi-rectilinear bladder retention structure can nolonger maintain the device at its proper location permitting the user tolater expel the device. Therefore, a need exists for an incontinenceprevention device having a retention structure that maintains itsappropriate position within the bladder neck regardless the physicalforces acting on it, and can recover after momentary bladder neck drop.

In addition, typical incontinence prevention devices require, at leastto some extent, that a proximal end extend from the urethral meatus. Theproximal ends tend to scatter urine droplets during urination. Thescattering of urine is inconvenient and unsanitary. Therefore, a needexists for a catheter that permits a directed stream of urine.

The present invention meet these needs and provides additionalimprovements and advantages that will be recognized by those skilled inthe art upon review of the following description and figures.

SUMMARY OF THE INVENTION

The present invention further provides an incontinence prevention devicethat is simple and inexpensive to construct and easy to use. Theincontinence prevention device of the present invention includes a shaftand a retention structure. The retention structure is configured as aclosed loop non-concentrically disposed about a longitudinal axis of theshaft. The retention structure's closed loop tends to maintain theincontinence prevention device within the bladder neck. The retentionstructure's non-concentrically orientation accounts for the bladder'sasymmetry. The retention structure may further include a protuberanceprojecting from the retention structure. The protuberance may projectfrom a midpoint of the closed loop. The shaft may further include alumen configured to receive a stylet. The lumen is typically coextensivewith the shaft and substantially coextensive with the retentionstructure. In addition, the lumen may be coextensive with theprotuberance. The device may also include a hydrogel coating disposed onits outer surface. The shaft may include an orientation marking at itsproximal end. The proximal end of the shaft may also have a beveled edgeto prevent the spraying of urine during urination. A segment of theretention structure may additionally define a cavity to receive anotherportion of the retention structure to further reduce the diameter forinsertion. For insertion, the retention structure is renderedsubstantially rectilinear. A stylet may be provided to insert into alumen in the device to render the retention structure substantiallyrectilinear. Once rectilinear, the device is inserted into the urethraso that the retention structure is placed within the bladder. Once inthe bladder, the retention structure is reformed into a loop. Theretention structure is then positioned adjacent the neck of the bladderwith the non-concentrically disposed retention structure in apredetermined orientation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of a urethral catheter showing afirst embodiment of the retention mechanism;

FIG. 2 illustrates a left end view of the urethral catheter of FIG. 1;

FIG. 3 illustrates a perspective view of a urethral catheter showing asecond embodiment of the retention mechanism;

FIG. 5A illustrates a side view of a stylet;

FIG. 5B illustrates a side view urethral catheter of FIG. 1 with astylet partially inserted into the urethra measuring device; and

FIG. 5C illustrates a side view urethral catheter of FIG. 1 with astylet fully inserted into the urethra measuring device.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is applicable to a variety of devices that aremaintained in the urethra. The invention is described in the context ofan incontinence device for a woman's urethra for exemplary purposes. Theappended claims are not intended to be limited to any specific exampleor embodiment described in this specification. It will be understood bythose skilled in the art that the present invention may be used inrelated medical applications including but not limited to incontinenceprevention devices, obstruction relief devices, drainage devices; orother similar devices which require retention in a lumen. Further, inthe drawings described below, the reference numerals are generallyrepeated where identical elements appear in more than one figure.

FIG. 1 illustrates an embodiment of an incontinence prevention device 10in accordance with the present invention. Device 10 includes a shaft 12,a retention structure 14 and a proximal retention structure 15. Device10 may further includes a lumen 18, shown in FIG. 2. Device 10 istypically circular in cross-section although other shapes such as ovalthat allow the sphincter to sealably contract against the catheter'souter surface may also be used. Device 10 is typically composed of aflexible biocompatible material such as silicone, silastic,polyurethane, polyethylene, polyimide, PTFE, ETFE, or other materials orcombinations of materials known to those skilled in the art. Typically,the material used has a durometer shore hardness of between about 30 and95 shore A. In addition, device 10 may be coated with a lubriciousmaterial, such as a bydrogel, to allow for easier insertion and reducedirritation.

Shaft 12 is typically configured as a semi-rigid region of device 10typically having a shape suitable for placement in the urethra Shaft 12is further configured to have sufficient rigidity for sphincter musclesto contract against it so as to substantially stop the flow of urinefrom a user's bladder. Shaft 12 may also include an orientation marking38, shown in FIGS. 5B and 5C and discussed below. The orientation makingmay either be visible, for example a line or dot, or tactile, forexample a crevice or dimple. Shaft 12 typically has a diameter of around8 French to correspond with an appropriate size for insertion in anadult female's urethra. The device can be made with various otherdiameters ranging from between about 5 to 16 French to enable the propersizing to accommodate the range of urethral sizes. The shaft typicallyhas a length of between about 3.5 to 4.5 centimeters enabling the propersizing of the catheter's length for most women's urethra. The proximalend includes a proximal retention structure 15. Proximal retentionstructure 15 generally functions to prevent the incontinence preventiondevice from moving up into the urethra and provides a means for grippingthe incontinence prevention device during removal. Proximal retentionstructure 15 is typically configured to conform to the vestibuleproximate the urethral opening. The proximal end of the shaft may alsoinclude a beveled edge 16. Beveled edge 16 tends to prevent the sprayingof urine during urination. In addition, the proximal end typicallyincludes a structure for preventing the incontinence prevention devicefrom tracking up the urethra.

Retention structure 14 comprises a closed loop at the distal end of theshaft non-concentrically disposed about shaft 12. Retention structure 14may be integral with shaft 12 or a separate element that is secured toshaft 12. FIG. 2 shows a proximal end view of device 10 of FIG. 1illustrating an embodiment of the non-concentric relationship of shaft12 to retention structure 14. Retention structure 14 projects in ageneral lateral direction from the shaft and is typicallynon-concentrically disposed about shaft 12. Retention structure 14 istypically shaped to be received at the base of the urinary bladder andabove the bladder's neck. Retention structure 14 maintains theincontinence prevention device in position as the bladder neck rises anddrops with patient activity. The retention structure is thought to bemaintained within the bladder as a moist watermelon seed is ejected whensqueezed between one's thumb and forefinger. Thus, when the retentionstructure slips below the neck and into the urethra, there is a tendencyfor the retention structure to be forced back into the bladder as thebladder neck and/or urethra resume their original orientation.Typically, a device having a retention structure in accordance with thepresent invention is capable of maintaining the catheter's positionregardless of the forces typically encountered. However, the device maybe removed by simply pulling on the proximal end with sufficient forceto collapse the retention structure.

The retention structure may be substantially circular, as shown in FIG.2, or may have various shapes appropriate for holding device 10 withinthe urethra that will be recognized by those skilled in the art. Theretention structure is configured to be collapsible for insertionthrough the urethra and to regain its shape after insertion once in thebladder. After insertion, the retention structure has sufficientrigidity to hold the retention structure within the urinary bladder. Toretain its shape, the retention structure may include an internal wireor be composed of a material with sufficient memory to regain the loopconfiguration.

In addition, FIG. 2 shows lumen 18 extending through the proximal end ofshaft 12.

FIG. 3 shows an alternative embodiment of the retention structure. Inthe embodiment of FIG. 3, retention structure 14 includes a protuberance22 projecting from the loop. In addition and as discussed in more detailbelow, a segment 21 may be attached to shaft 12 to form the loop and toprovide protuberance 22. Protuberance 22 forms a smaller leading tip foreasier insertion and helps to maintain the incontinence preventiondevice on a stylet during insertion. To facilitate this, protuberance 22typically includes a lumen that is coextensive with lumen 18 of shaft12. That is, lumen 18 extends from a proximal end incontinenceprevention device 10 to a distal end 26. Typically, the lumen does notextend through distal end 26 but only to a point immediately proximal todistal end 26. This configuration prevents the flow of urine through thelumen. Alternatively, the incontinence prevention device may have thelumen extending through distal end 26 to allow fluid flow through thelumen as required for some applications. When the retention structureincludes a portion of the shaft, a segment 21 is typically provided tocomplete the loop comprising retention structure 15. Segment 21 istypically attached at one end to a first location proximate to distalend 26 of shaft 12 and, at the segment's other end, to a second locationalong the shaft closer to the shaft's proximal end so as to form a loop.Typically, the length of segment 21 and the positions for its attachmentare selected so as to permit the loop to assume an appropriateconfiguration for insertion into the urethra and subsequent reformationinto a loop when in the bladder.

Shaft 12 and segment 21 may be configured to appear as a single unit forinsertion. That is, when you straighten out the loop the two elementshave the appearance of being one element. One such configuration mayinclude configuring segment 21 as a horseshoe defining a cavity 23, asshown in cross-section in FIG. 4. Shaft 12 is then shaped to be receivedwithin cavity 23. When the loop is collapsed, cavity 23 receives shaft12 and the retention structure appears as one element instead of aseparate segment 21 and shaft 12. The actual circumference of theretention structure is therefore reduced making it physically easier toinsertion and less traumatic on the patient. In addition, the thinnerappearance would tend to be less intimidating to a patient.

The shaft and retention structure may be composed of a uniform materialor may be composed of layers of material to confer the desiredcharacteristics. When layered, the structure may include, for example,an inner layer of polyurethane surrounded by an outer layer of siliconeor other combinations that confer desired characteristics. For example,the layered structures may be formed by inserting a polyurethane tubeinside a silicone sleeve. The fit between the polyurethane tube andsilicone sleeve is such that their contact minimizes slippage betweenthe two. To develop sufficient contact, the silicone sleeve is typicallysoaked in a suitable solvent to swell the sleeve. The polyurethane tubeis then inserted into the sleeve. As the solvent evaporates, thesilicone sleeve contracts against the polyurethane tube. Typically, onlythe shaft is provided with such a silicon sleeve.

Using the above method of manufacture, the polyurethane tube holds thestructure together while the silicone provides an appropriate surfacefor the sphincter to contract against. In addition, the retentionstructure may be integral with the shaft or formed independent of theshaft. When integral, device 10 may be formed from a single tube havingits distal end wrapped around and secured to the tube to separatelydefine the shaft and the retention structure. When formed independently,the retention structure may have a different shape and physicalcharacteristics than the shaft.

The method of using a incontinence prevention device in accordance withthe present invention is best understood with reference to FIGS. 5A, 5Band 5C. The figures illustrate a method of linearizing a device 10, asshown in FIG. 1, for insertion into the urethra. FIG. 5A shows aninsertion tool 30 having a handle 32 attached to a stylet 34. Handle 32is not required but is typically provided for better control of thecatheter during insertion. Stylet 34 is composed of a material,typically a metal wire, having sufficient rigidity to facilitate theinsertion of the catheter into the urethra. Stylet 34 is typically sizedto fit within lumen 18 of device 10. In use, stylet 34 is inserted intoshaft 12 through lumen 18 at the shaft's distal end, as shown in FIG.5B. Stylet 34 is advanced into shaft 12 through lumen 18. Once thestylet's distal end reaches retention structure 14, retention structure14 assumes a conformation allowing insertion through the urethra, asshown in FIG. 5C, due to forces conferred by stylet 34. At this point,lubrication is typically applied to device 10. If the device is hydrogelcoated, the device is lubricated simply by moistening the material.Alternatively, a water-soluble lubricant, like K-Y Jelly, or othersuitable lubricant may be applied to the catheter's surface. In theembodiment shown, stylet 34 is typically advanced until retentionstructure 14 collapses in on itself due to the rigidity of the styletand the tension exerted between the distal tip of stylet 30 and thepoint 36 where the loop attaches to shaft 12. Thus, insertion of thestylet renders urethral catheter 14 substantially rectilinear so as toallow insertion into a urethra. Retention structure 14 is then insertedinto the urethra. Once retention structure 14 of the incontinenceprevention device 10 is positioned within the urinary bladder, thestylet is removed allowing retention structure 14 to resume its originalconfiguration. The proximal end of device 10 is then manipulated, ifnecessary, to properly orient non-concentrically configured retentionstructure 14 adjacent to the bladder neck within the patient. Theorientation of retention structure 14 may be reflected by reference toorientation marking 38 on shaft 12. Thus, for example, when orientationmarking 38 is oriented ventrally, retention structure 14 is properlyoriented within the patient's bladder.

1. An incontinence prevention device comprising: (a) a flexible shaftmember sized to fit within the urethra of a female; and (b) a retentionstructure formed on a distal end of the flexible shaft, the retentionstructure forming a perimeter of a closed loop defining a plane that isgenerally perpendicular lateral to a longitudinal axis of the flexibleshaft when the retention structure is unrestrained, said longitudinalaxis being offset from a center of the closed loop so as to pass throughthe perimeter of the closed loop.
 2. An apparatus, as in claim 1,further comprising a lumen configured to receive a stylet, wherein thelumen is coextensive with the shaft and substantially coextensive withthe retention structure.
 3. An apparatus, as in claim 1, furthercomprising a hydrogel coating disposed on an outer surface of thecatheter.
 4. An apparatus, as in claim 1, wherein the shaft includes anorientation marking at a proximal end of the shaft.
 5. An apparatus, asin claim 1, wherein a proximal end of the shaft includes a beveled edge.6. An apparatus, as in claim 1, wherein the retention structure furtherincludes a protuberance projecting from the retention structure.
 7. Anapparatus, as in claim 6, wherein the protuberance projects from amidpoint of the closed loop.
 8. An apparatus, as in claim 6, furthercomprising a lumen coextensive with the shaft and protuberanceconfigured to receive a stylet.
 9. An apparatus, as in claim 8, whereinthe lumen extends through a distal end of the protuberance.
 10. Anapparatus, as in claim 8, wherein the lumen extends to a point proximalto a distal end of the protuberance.
 11. An apparatus, as in claim 6,wherein a segment of the retention structure defines a cavity to receivea portion of the retention structure.
 12. A method treatingincontinence, comprising: providing an apparatus including a shaft and aretention structure, wherein the retention structure forms a perimeterof a closed loop defining a plane that is generally perpendicularlateral to a longitudinal axis of the shaft and the longitudinal axis ofthe shaft is offset from a center of the closed loop and passes throughthe perimeter of the closed loop when the retention structure isunrestrained; rendering the retention structure substantiallyrectilinear; inserting the rectilinear retention structure through aurethra into a bladder; reforming the retention structure into theclosed loop; and positioning the retention structure adjacent the neckof the bladder with the retention structure in a predeterminedorientation.
 13. The method, as in claim 12, wherein the apparatusfurther comprises a lumen configured to receive a stylet, wherein thelumen is coextensive with the shaft and substantially coextensive withthe retention structure.
 14. The method, as in claim 13, (12, furthercomprising providing a stylet and) wherein the stylet is inserted intothe lumen in the apparatus to render the retention structuresubstantially rectilinear.